Taurolidine-heparin catheter lock solution
Background: Catheter-related bloodstream infections (CRBSIs) are one of the most prevalent, fatal, and costly complications of hemodialysis with a central venous catheter (CVC). The LOCK IT-100 trial compared the efficacy and safety of a taurolidine/heparin catheter lock solution that combines taurolidine 13.5 mg/mL and heparin (1000 units/mL) versus heparin in preventing CRBSIs in participants receiving hemodialysis via CVC.
Methods: LOCK IT-100 was a randomized, double-blind, active-control, multicenter, phase 3 study that enrolled adults with kidney failure undergoing maintenance hemodialysis via CVC from 70 US sites. Participants were randomized 1:1 to taurolidine/heparin catheter lock solution or heparin control catheter lock solution (1000 units/mL). The primary endpoint was time to CRBSI as assessed by a blinded Clinical Adjudication Committee. Secondary endpoints were catheter removal for any reason and loss of catheter patency. Based on a prespecified interim analysis, the Data and Safety Monitoring Board recommended terminating the trial early for efficacy with no safety concerns.
Results: In the full analysis population (N=795), 9 participants in the taurolidine/heparin arm (n=397; 2%) and 32 participants in the heparin arm (n=398; 8%) had a CRBSI. Event rates per 1000 catheter-days were 0.13 and 0.46, respectively, with the difference in time to CRBSI being highly statistically significant, favoring taurolidine/heparin (P<0.001). The hazard ratio was 0.29 (95% confidence interval: 0.14, 0.62), corresponding to a 71% reduction in risk of CRBSI with taurolidine/heparin versus heparin. There were no significant differences between study arms in time to catheter removal for any reason or loss of catheter patency. The safety of taurolidine/heparin was comparable to that of heparin, and most treatment-emergent adverse events were mild or moderate.
Conclusions: Taurolidine/heparin reduced risk of developing a CRBSI in study participants receiving hemodialysis via CVC compared with heparin with a comparable safety profile.
Agarwal AK, Roy-Chaudhury P, Mounts P, Hurlburt E, Pfaffle A, Poggio EC. Taurolidine/Heparin Lock Solution and Catheter-Related Bloodstream Infection in Hemodialysis: A Randomized, Double-Blind, Active-Control, Phase 3 Study. Clin J Am Soc Nephrol. 2023 Sep 6. doi: 10.2215/CJN.0000000000000278. Epub ahead of print. PMID: 37678222.